NEAAR-LARC: Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC) (NCT06380101)
NEAAR-LARC: Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)
Intervencionista
Fase no especificada
University of South Florida
This clinical study aims to assess feasibility, safety, tolerability, and compliance of a Nonessential Amino Acid Restriction (NEAAR) medical food in adult patients with locally advanced rectal cancer during standard of care short course radiotherapy followed by standard of care chemotherapy.
Categoría de tratamiento
Otros
Erforderliche Mutationen
Ninguna
Ensayo iniciado
2023-09-08
Última actualización por el patrocinador
2024-04-23
Finalización estimada
2024-12-01
Elegibilidad
Criterios de inclusión
* Histologically confirmed diagnosis of adenocarcinoma of the rectum
* Clinical stage II (cT3-4, N-) or Stage III (cT any, N+) based on MRI
* Eligible for total mesorectal excision
* No evidence of distant metastasis
* No prior pelvic radiation therapy
* No prior chemotherapy
* Age ≥18 years
Criterios de exclusión
* Patients unable to undergo MRI
* Other anticancer or experimental therapy
* Body mass index (BMI) <18.5 kg/m2 or >40 kg/m2
* Serious or refractive cachexia or anorexia
* Insulin-dependent diabetes Taking or needs to take any protein or amino acid containing nutritional supplements (e.g., Ensure®) Patients with a condition where high-fat or fatty food is contraindicated History of confirmed food allergy Active wound or skin graft that would require a significant increase in protein requirements for skin integrity and healing
¿Cree usted que este ensayo clínico se muestra por error?
Detalles del diseño
AsignaciónN/A
Modelo de intervenciónSingle Group Assignment
EnmascaramientoNone (Open Label)
Número a inscribir30
Brazos e Intervenciones
Brazos
Intervenciones
Tipo: Experimental
Descripción: This is a single arm study in which all subjects will receive NEAAR medical food.
Intervenciones:
NEAAR Medical Food
Medidas de resultado
Medidas de resultado primarias
Rate of CTCAE v5.0 non-hematological Grade 3 and higher diarrheaDuring standard of care Short-course radiotherapy and total neoadjuvant therapy, up to approximately 1 year
Medidas de resultado secundarias
Proportion of clinical complete response 8 weeks post SCRT-TNT with NEAAR medical food defined by the MSK Regression Schemaapproximately 8 weeks after SCRT-TNT with NEAAR medical food intervention
Absolute and relative change from baseline of circulating non-essential amino acidsfrom baseline up to approximately 8 weeks after SCRT-TNT with NEAAR medical food intervention
Proportion of clinical complete response at Week 4 post SCRT with NEAAR medical foodapproximately 4 weeks after SCRT with NEAAR medical food intervention
molecular ctDNA response.approximately 4 weeks after SCRT with NEAAR medical food intervention and 8 weeks post SCRT-TNT with NEAAR medical food intervention.
¿Interesado en participar?
Obtenga más información sobre este ensayo y si puede ser elegible para participar.
Guardar ensayo
Compartir ensayo por correo electrónico
Descargar ensayo
¿Cree usted que este ensayo clínico se muestra por error?